Kornimate/medical-research-clean huggingface dataset:
effect of orange juice and healthy diet on cardiometabolic risk factors of individuals with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this study aimed to verify if combination of a healthy diet and orange juice consumption can minimize cardiometabolic risk factors for metabolic syndrome (mets)

the clinical study was parallel, controlled, and randomized with metabolic syndrome subjects (atpiii, aha / nhla) aimed at the consumption of an energy-balanced balanced diet for 12 weeks and divided into two groups: control (n = 38): dietary guidance only; and orange juice (n = 38): diet guidance associated with 500 ml / day of 100% whole orange juice. the recruitment process began in june 2016, the intervention was carried out from september 2016 to december 2016, and the data analysis started in january 2016. the sample number took into account variances on ldl-c, with a type i error α = 0.05 and a type ii error β = 0.2 (80% power). the minimum sample size should have 32 individuals per group (n = 64). considering an approximately 15% dropout rate, the final sample size of study was constituted by 38 individuals per group. primary and secondary endpoints were the reduction of ldl-c and modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics parameters, respectively. kolmogorov smirnov and levene test assessed normality and homogeneity of data, respectively. t-test was conducted to identify possible differences between oj and control groups at baseline. a linear mixed-effects model was apply to determine the time effect within and between groups (sidak post hoc) and p significance was set up ≤ 0.05. the assessment of body composition, metabolic biomarkers and food intake were analyzed over a 12-week intervention.

Eligibility criteria:
inclusion criteria: * three or more of the risk factors of ms: (1) waist circumference man ≥ 102 cm and woman ≥ 88 cm; (2) triglycerides ≥ 150 mg / dl; (3) hdl-c man ≤ 40 mg / dl and woman ≤ 50 mg / dl; (4) blood pressure ≥ 130 / ≥ 85 mm hg and (5) fasting glucose ≥ 100 mg / dl (common diabetes, high blood pressure); * 25 ≥ bmi ≤ 39.9 kg / m - overweight to grade ii obesity; * like to consume orange juice; exclusion criteria: * pregnant / nursing; * use of vitamins or vitamin-food supplements in the last three months; * individuals with diseases that require specific diet recommendations such as diabetes mellitus with insulin therapy and carbohydrate counts, cancer, chronic liver and kidney disease.

Keywords: orange juice healthy diet metabolic syndrome cardiometabolic risk factors body composition
adherence to medical treatments for telemedicine patients

Conditions: Stroke; Medication Adherence

Summary: this study will test the feasibility of medrem, a novel medication reminder and tracking system on wearable wrist devices, specifically with the apple watch 4. the study team will load the medrem app onto two apple watch 4s for use during the study. as the device is placed on the wrist, it is free from the limitations of smartphones. however, one of the major challenges in developing interactive systems for wrist devices is their form factor. the touch screens available on these devices are tiny and much smaller compared to smart phones and tablet computers. medrem enables user interactions by incorporating speech recognition and text-to-speech features along with clever interface design. the tiny display of the device is used for minimal inputs and outputs, while a user can retrieve and provide more information from/to the system through voice commands. personalized models are built and updated over time to reduce errors in recognizing users' voice commands, and thus better user experience is provided.


Eligibility criteria:
inclusion criteria: * phase 1 (controls) * 18 - 75 years old * good general health (self-reported), with no history of cerebral vascular accident (cva) * english-speaking * willingness and ability to comply with scheduled visits and study procedures phase 2 (stroke patients) * 18 - 75 years old * english-speaking * willingness and ability to comply with scheduled visits and study procedures * have requirements for home- based therapy regimens (i.e. physical/occupational therapy) * require medications for secondary stroke prevention (e.g. antithrombotic therapy to prevent ischemic stroke, stroke risk factor management with blood pressure, diabetes, cholesterol medications). * have a modified rankin scale for neurologic disability (mds) of 2 - 4 exclusion criteria: * phase 1 (controls) * pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-english speaking subjects * prohibitive cognitive impairments or language deficits * does not have wireless internet connection at home phase 2 (stroke patients) * pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-english speaking subjects * have a modified rankin scale for neurologic disability (mds) of 0-1 or 5 * prohibitive cognitive impairments or language deficits * significant weakness, dystonia, or spasticity that will prevent proper use and response to the apple watch device * live in nursing home or rehabilitation facility * does not have wireless internet connection at home

Keywords: remote monitoring
national survey among egyptian pain practitioners

Conditions: Survey

Summary: coronavirus pandemic health restrictions has deleteriously affected the rates of all interventional procedures even for emergency cases. this study tried to evaluate the impact of the outbreak of sars-cov-19 infection on rates of interventional pain therapy (ipt).

background: coronavirus pandemic health restrictions has deleteriously affected the rates of all interventional procedures even for emergency cases. this study tried to evaluate the impact of the outbreak of sars-cov-19 infection on rates of interventional pain therapy (ipt). methods: setting: multicenter study. design: prospective observational study, approved by the local ethical committee (rc:2-1-21). materials: two 20-item questionnaires with five choices for probable answer using a likert-5 point scale were constructed as self-assessment questionnaire. the questionnaires were uploaded to the google drive, and the links and identification codes were sent using the whatsapp to 500 ipt providers. the feedback answers were scored and statistically analyzed. statistical analyses will be performed using ibm® spss® statistics (version 22, 2015; armonk, usa) for windows statistical package. p value \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: registered pain practitioners in egypt. - exclusion criteria: non registered pain practitioners
music during pulmonary rehabilitation for patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is aimed at determining whether listening to music during exercise will improve health-related outcomes for individuals with chronic obstructive pulmonary disease (copd). half of the participants will listen to music while they exercise and half will not listen to music. the study will follow participants during their pulmonary rehabilitation program and for 6 months following completion of the program.

people with chronic obstructive pulmonary disease (copd) are encouraged to undertake exercise training as part of their treatment. however, they often find themselves limited by breathlessness and tiredness in their legs. these barriers limit how much a person may benefit from an exercise program and how well they may keep up with a recommended schedule of exercise at home. one way of reducing feelings of breathlessness and leg tiredness is by listening to music during exercise. the impact of adding music to exercise versus exercise alone has not been explored in the setting of pulmonary rehabilitation. this study is aimed at determining the effect of listening to music during exercise sessions on exercise capacity, symptom severity, quality of life and motivation to exercise. people with copd will be randomly allocated to exercise plus music or exercise alone. a music therapist will aid with music selection for the exercise plus music group and the music will be loaded onto a portable device that participants will listen to with earbuds. all participants will complete assessments before starting a pulmonary rehabilitation program, at the end of the 8-10 week program and 6 months following completion of the program. they will complete walking tests, report symptom severity and complete a series of questionnaires asking about their quality of life, symptoms and keenness to exercise.

Eligibility criteria:
inclusion criteria: * medical diagnosis of copd (physician diagnosis and spirometry with fev1/fvc ratio \<70) and smoking history of greater than 10 pack years * stable clinical state, with no acute exacerbations over the last 6 weeks * referred to pulmonary rehabilitation program exclusion criteria: * predominant diagnosis other than copd (asthma, bronchiectasis, interstitial lung disease) * co-morbidities (orthopaedic, neurological, cardiac) which might prevent safe exercise training * substantial hearing difficulties (inability to hear music adequately) * regularly uses music when exercising

Keywords: copd music exercise
the effect of mifepristone on uterine fibroids and breast tissue

Conditions: Uterine Fibroids

Summary: uterine fibroids are a benign but common condition among women in reproductive age. it is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. several alternative treatment regimens have been investigated that could replace surgery. the antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. in addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue. the purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. the study will also address the effect of mifepristone on the breast tissue

other purposes of this study include: * to develop a new non-surgical method for treatment of uterine fibroids * to study the effect of mifepristone on the size of uterine fibroids * to evaluate factors regulating fibroid growth by comparison with untreated fibroids and normal myometrium * to study the effect of mifepristone on the amount of blood loss and pelvic pain in patients with fibroids * to study the effect of mifepristone on proliferation of breast tissue

Eligibility criteria:
inclusion criteria: uterine fibroids requiring treatment * good general health * willing and able to participate after giving informed consent exclusion criteria: * need for immediate surgery * concomitant hormonal treatment (hrt) * history of malignant disorder of the breast * any contraindication for mifepristone criteria for retrospective exclusion: subjects may be excluded from analysis if one of the following applies: * any violation of the study protocol * lack of essential data

Keywords: mifepristone leiomyomas breast epithelial cell proliferation
to investigate the molecular mechanism of traditional chinese medicine constitution using next-generation sequencing in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: to investigate the molecular mechanism of traditional chinese medicine constitution, the investigators proposed a randomized, double-blind, placebo-controlled, phase ii trial to recruit 120 patients with nasopharyngeal cancer. next generation sequencing, immune repertoire, gut microbiota, traditional chinese medicine constitution and tongue diagnosis would be examined before/after 16 weeks of treatment of danggui buxue tang from the beginning of concurrent chemoradiotherapy in this project. the correlation between different examinations would be analyzed to investigate the molecular mechanism of traditional chinese medicine constitution. disease survival, recurrence, and quality of life would be also followed up for two years to evaluate the benefit of danggui buxuetang.

the basis for academic excellence is the interdisciplinary cooperation. the individualized medicine is the future trends, and the theory of body constitution is the most potential study for the individualized medicine and to research the process and prognosis of disease. technique of next-generation sequencing (ngs) is also involved to comprehend to the mechanism of the prescriptions under the theory of body constitution. the nasopharyngeal cancer is a chinese-specific disease, and radiation therapy has remarkable effect. there are many studies proving that traditional chinese medication can relieve the side effect of radiation therapy. the study will combine next-generation sequencing and tcm diagnostic tool, and analyze the transformation of body constitution and the performance of genes related to radiation therapy. the results may reveal the molecular mechanism of tcm constitutions and the benefit of danggui buxuetang, and may be used for early screen and prevention to other cancers or diseases. furthermore, it can help to develop the potential drugs. the study plans to collect 120 cases within two years. the participants would be divided randomly to the experimental group and control group. the blood sample would be taken for next generation sequencing analysis before the radiation therapy, and after the radiation therapy combined with traditional chinese medication. the result of samples would be compared with each other to identify "qi deficiency gene" and "tcm effective gene".

Eligibility criteria:
inclusion criteria: patients with pathological diagnosis of nasopharyngeal carcinoma stage ii \~ iva (ajcc eighth edition) preparing to receive concurrent chemoradiotherapy exclusion criteria: * pregnant or lactating women * ecog ps (ecog performance status) scores of over 2 points for each day's performance assessment * take anticoagulants or antiplatelet agents such as aspirin, warfarin, etc. * cannot accept routine treatment, or can not cooperate with the research program

Keywords: nasopharyngeal carcinoma concurrent chemo-radiotherapy
efficacy study of ifabond in breast cancer surgery

Conditions: Breast Cancer; Lymphocele

Summary: a randomized prospective simple-blind interventional study evaluating the efficacy of the synthetic adhesive solution "ifabond", in patients undergoing breast cancer surgery. the main objective of this study is to determine if the application of ifabond, in addition to the conventional method of breast surgery, reduces the postoperative seroma formation. the secondary objective is to assess quality of life immediately after surgery, and the need for needle aspiration of the axilla, when using ifabond.

breast cancer patients will be selected at their preoperative visit with the surgeon, who will inform them about the study and answer their questions. patients who consent to participate will be randomized to one of two arms: 1. arm a: applying ifabond 2. arm b: without ifabond patients will be stratified according to these two criteria: 1. axillary lymph node dissection planned (alnd) 2. body mass index (bmi) the following parameters will be measured: * ecog status and blood pressure at day 3(day 7 in case of alnd), day 15 and day 30 post surgery * volume of drainage at day 3 and at (day 7 in case of alnd)post surgery * discomfort alleged by the patient at day 3(day 7 in case of alnd), day 15 and day 30 post surgery * lymphocele volume measured by ultrasound at day 15 and day 30 post surgery * if the volume is ≥ 100cc, a needle aspiration will be performed, and the volume of aspirate will be documented. * adverse events and concomitant medications will be collected throughout the study until 30 days after the last ultrasound.

Eligibility criteria:
inclusion criteria: * "eastern cooperative oncology group" ecog status ≤ 2 * diagnosis of invasive or in situ breast cancer * patient undergoing partial mastectomy with or without axillary lymph node dissection,(without communication between the two surgical loges) exclusion criteria: * pregnant or breast-feeding patient * participation at another protocol with an investigational drug (within the last 4 weeks before enrollment) * known hypersensitivity to cyanoacrylate * known hypersensitivity to formaldehyde * patient who experience systemic infections preoperatively, or have conditions that are known to interfere with the healing process * patient with uncontrolled diabetes
rrx-001 in second line treatment of advanced cholangiocarcinoma prior to readministration of first-line therapy

Conditions: Cholangiocarcinoma

Summary: the purpose of this study is to see if the investigational drug, rrx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. the name of the open-label study, which means that patients will know what treatments they are receiving, is epic, a hybrid or combination of epigenetic for the mechanism of action of rrx-001 and cholangiocarcinoma. the study treatment is divided into two stages. during the first stage, patients will receive rrx-001, which is administered intravenously weekly, for a fixed time period of six weeks. at that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred. the primary objective of this clinical trial is to evaluate the progression-free survival (pfs) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/cholangiocarcinoma * must have locally advanced or distant metastatic disease that is not surgically curable * failed first-line chemotherapy * age ≥ 18 years * life expectancy of at least 12 weeks (3 months) * performance status 0 or 1 * adequate liver, kidney, and bone marrow function exclusion criteria: * symptomatic metastatic brain or meningeal tumors * investigational compound within 4 weeks of enrollment * history of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity) * any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation * pregnant or nursing * substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results * albumin \<2.8 * uncontrolled or clinically relevant ascites * absolute contraindication for mri imaging such as intracorporeal metal or pacemaker
90% effective dose of phenylephrine infusions under intensive and standard treatment in preeclamptic patients

Conditions: Adverse Effect

Summary: the objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. the 2016 asa guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. the 2018 international consensus in the united kingdom and northern ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. the objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification i to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥160 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly
a placebo-controlled study to investigate the safety, and pharmacokinetics of oral gsk626616ac in healthy subjects

Conditions: Healthy Subjects; Anaemia

Summary: this is a first time in human study to investigate the safety of gsk626616ac given as oral single and repeat doses in healthy subjects. an additional group of subjects will be assessed to determine the effect of several drugs given at the same time as gsk626616.


Eligibility criteria:
inclusion criteria: * age 18 to 55 years healthy subjects * hemoglobin values of 13.5-17.0 g/dl for males or 12.0-15.5 g/dl for females. * females cannot be pregnant. exclusion criteria: * cannot have exposure to greater than 4 new chemical entities within 12 months. * cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule. * cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months. * must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry. * cannot use be taking prescription, non-prescription or illicit drugs.

Keywords: repeat dose, gsk626616ac, pharmacokinetic, single dose, cytochrome p450, first time in human, healthy volunteers